Manager of Regulatory Operations

Job Summary

Reporting to the Associate Director, Regulatory Operations and Publishing, the full-time Manager of Regulatory Operations will manage submission activities by supporting cross-functional departments, focusing on document processing, formatting, and eCTD publishing in a remote environment.

Key responsibilities

• Assist in the preparation and compilation of regulatory submission documents in compliance with global requirements
• Analyze and develop processes using the Veeva Vault RIM suite to support business needs
• Conduct final quality reviews of published documents to ensure compliance prior to dispatch

Required qualifications

• Bachelor's degree with 5-6 years of experience in Regulatory Operations, particularly in electronic submissions
• Expertise in Word processing, formatting, and PDF publishing for electronic submissions
• Experience with electronic document management and publishing systems, such as Veeva Vault RIM
• Proficiency in MS Word and Adobe; knowledge of Accenture StartingPoint Templates is a plus
• Ability to work independently and efficiently with Regulatory Affairs